The following data is part of a premarket notification filed by Roxwood Medical, Inc. with the FDA for Centercross Ultra Lv Catheter.
| Device ID | K170403 |
| 510k Number | K170403 |
| Device Name: | CenterCross Ultra LV Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Roxwood Medical, Inc. 400 Seaport Ct, Suite 103 Redwood City, CA 94063 |
| Contact | Mehrdad Farhangnia |
| Correspondent | Mehrdad Farhangnia Roxwood Medical, Inc. 400 Seaport Ct, Suite 103 Redwood City, CA 94063 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-09 |
| Decision Date | 2017-03-07 |
| Summary: | summary |